CTRI/2023/09/057633招募中不适用
A multi-center, open-label, balanced, randomized, two-treatment, two-period, two-sequence, two-way crossover, multiple-dose, steady-state bioequivalence study of Pazopanib HCl Tablets 200 mg (4 Tablets X 200 mg) of MSN Laboratories Private Limited, India compared with Votrient® Tablet 200mg (4 Tablets X 200 mg) of Novartis Pharmaceuticals Corporation, USA in Advanced renal cell carcinoma patients who are already receiving Pazopanib HCl tablets in standard therapy, and who are tolerating a stable dosing regimen of 800 mg/day under fasting conditions.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 17
- 主要终点
- To assess the bioequivalence of Pazopanib HCl Tablets 200 mg (4 Tablets X 200 mg) of MSN Laboratories Private Limited, India with Votrient® Tablet 200mg (4 Tablets X 200 mg) of Novartis Pharmaceuticals Corporation, USA, among Advanced renal cell carcinoma patients who are already receiving Pazopanib HCl tablets in standard therapy, & who are tolerating a stable dosing regimen of 800 mg/day under fasting conditions
研究概览
简要总结
A multicentre, randomized, two way crossover bioequivalence study, comparing Pazopanib hydrochloride in Test and Reference drugs, in patients with Advanced Renal Cell Carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients should fulfil all inclusion and none of the Exclusion criteria for enrolment in the study.
- •Male or non-pregnant female patients between
- •75 years of age.
- •Patient willing to give written informed consent and comply with treatment and follow up.
- •Patient whose organ and immune system functions are normal or adequate as indicated by the laboratory values or considered by the Investigator/sub-Investigator to be of no clinical significanceâ€. Hematologic:Absolute neutrophil count (ANC) ≥ 1.5 X 109/L Platelets ≥ 100 X 109/L Hemoglobin ≥ 9.0 g/dL Prothrombin Time (PT) ≤ 1.2 X ULN International Normalized Ratio (INR) ≤ 1.2 X ULN activated Partial Thromboplastin Time (aPTT) ≤ 1.2 X ULN,Hepatic:Total bilirubin ≤ 1.5 X ULN AST and ALT ≤ 2.0 X ULN,Renal;Serum creatinine ≤ 2 mg/dL Creatinine clearance ≥ 30 mL/min
- •Histopathological or Radiological diagnosis (Only PET Scan) of advanced RCC patient.
- •No significant medical comorbidities or inter current illnesses that could limit compliance with study medications or increase the risk of treatment-related toxicities.
- •Patients with confirmed advanced RCC who are on a stable dose (at least 28 days) of pazopanib tablets 800 mg once daily.
- •Patient, who in the opinion of the Investigator has a life expectancy greater than or equal to 3 months from the time of the first dose.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2(Appendix 4).
- •No persistent toxicities from prior medications [Recovery to baseline or less than or equal to Grade 1 Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (or) higher and/or stable on supportive therapy at screening visit if any toxicities had occurred unless the toxicities were clinically insignificant].
- •Patient with cardiac ejection fraction within the normal range as measured by echocardiogram.
- •The patient must have a clinically acceptable 12-lead ECG at screening including QTc interval ≤ 480 msec.
- •Patient must have clinically acceptable results for all the screening parameters and investigations.
- •Able to swallow and retain orally administered medication.
- •Availability of patient for the entire study duration and willingness to adhere to protocol requirements as evidenced by written informed consent.
- •Female patient a) of childbearing potential practicing an acceptable method of birth control such as sexual abstinence, (other than hormonal contraceptives) e.g. barrier method (diaphragm, condom, etc.); for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same during treatment and for at least two weeks after the last dose or withdrawal/ discontinuation from the study. The patient agrees to accept the risk that pregnancy could still result despite using birth control devices. OR b) Postmenopausal for at least the past 12 months. OR c) Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/hysterectomy has been performed on the patient).
- •Male patient must agree to practice an acceptable method of birth control such as sexual abstinence, a barrier method of contraception (i.e. condom) for the duration of the study as judged by the investigator(s)/study physician and agree to follow the same treatment and for at least two weeks after the last dose treatment or discontinuation /withdrawal from the study. The patient agrees to accept the risk that pregnancy in a female partner could still result despite using birth control devices.
排除标准
- •1.Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half lives of enrollment, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- •2.If patient’s current dose cannot be given using multiples of the dosage strength being studied 3.ECOG performance status 2 4.Pregnant or nursing (lactating) women 5.Hypokalemia, hypomagnesemia, long QT syndrome, or a history of cardiac disease.
- •6.Receiving any medications or substances that are strong inhibitors or inducers of the CYP450 enzyme.
- •7.Receiving any drugs known to prolong the QT interval within 4 weeks prior to study or during the study.
- •8.Unable to swallow and retain orally administered medication.
- •9.Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to beginning study treatment.
- •10.Any of the following cardiovascular conditions: •history or presence of stable or unstable ischemic heart disease (IHD), myocardial infarction, myocarditis, or cardiomyopathy •history of angina pectoris due to coronary spasm •cardiac failure at time of Screening (Class II- IV, according to NYHA Classification) or any severe cardiac disease as determined by the investigator •history of cardiac arrest •history or presence of a clinically relevant impairment of cardiac conduction including sick sinus syndrome, or sino-atrial heart block, clinically significant AV block, bundle branch block or QTc 450 msec for males and 470 msec for females at Screening ECG •history or presence of symptomatic arrhythmia or arrhythmia requiring treatment or being otherwise of clinical significance •history of syncopes of suspected cardiac origin 11.Any of the following pulmonary conditions: •pulmonary fibrosis or any severe respiratory disease •tuberculosis, subjects receiving chronic (daily) therapies for asthma •subjects with any other types of clinically significant bronchoconstrictive disease 12.Repeated and confirmed laboratory findings showing: •known history of alcohol abuse, chronic liver or biliary disease •total bilirubin greater than the upper limit of the normal range (ULN) unless in context of Gilbert’s syndrome •conjugated bilirubin greater than the 1.5 x ULN •alkaline phosphatase (AP) greater than 1.5 x ULN •AST (SGOT), ALT (SGPT) greater than 2 x ULN •platelets ≤ 100,000/µL •Any signs of severe anemia.
- •â€¢ANC 1500/mm3 (1500 / µL) 13.Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drug, or which may jeopardize the subject in case of participation in the study.
- •14.Positive alcohol or drug abuse test at screening.
- •15.Have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to randomization.
- •16.Significant illness within the two weeks prior to dosing or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study.
- •17.Current history of active systemic bacterial, viral or fungal infections 18.Diagnosis of AIDS, Hepatitis B, Hepatitis C infection defined as a positive HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody tests, respectively.
- •19.History of hypersensitivity to Pazopanib compound and/ or its class.
- •20.Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or any medically unstable condition, as assessed by the primary treating physician which, in the opinion of the investigator, would compromise the subject and/or place the subject at unacceptable risk for participation in a study.
- •22.Any other condition or abnormal findings that, in the investigator’s judgment, might increase the risk to the subject or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
- •23.Subject with a history of difficulty in donating blood or difficulty in accessibility of veins.
结局指标
主要结局
To assess the bioequivalence of Pazopanib HCl Tablets 200 mg (4 Tablets X 200 mg) of MSN Laboratories Private Limited, India with Votrient® Tablet 200mg (4 Tablets X 200 mg) of Novartis Pharmaceuticals Corporation, USA, among Advanced renal cell carcinoma patients who are already receiving Pazopanib HCl tablets in standard therapy, & who are tolerating a stable dosing regimen of 800 mg/day under fasting conditions
时间窗: A total of 19 blood samples (1 x 03 mL) will be collected from each patient in each period. | The pre-dose blood sample at 0.00 hr (1 x 03 mL) will be collected within 0.50 hr of scheduled dosing time on days 12, 13, & 14 in period I & 26, 27 & 28 in period II. | On days 14 (period I) and 28 (period II), blood samples will be collected at 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 4.50, 5.00, 6.00, 08.00, 10.00, 12.00, 16.00 and 24.00 hours post dose.
次要结局
- To monitor the safety & tolerability of Pazopanib HCl Tablets 200 mg (4 Tablets X 200 mg) among Advanced renal cell carcinoma patients who are already receiving Pazopanib HCl tablets in standard therapy, and who are tolerating a stable dosing regimen of 800 mg/day under fasting conditions(28 days)
研究者
研究点 (17)
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